Organization


CYCLOTRON & RADIOPHARMACEUTICALS DEPARTMENT - RIYADH

5782

 

 

Introduction

Cyclotron and Radiopharmaceuticals Department (C&RD) is a state-of-the art facility for two primary activities: Radiopharmaceuticals manufacturing, and Radioisotope research.

Radiopharmaceuticals manufacturing program is not only quite unique even for a major medical center, but also an essential component of KFSH&RC in providing the specialty services and quality patient care for the population of the Kingdom. On-demand and reliable availability of radiopharmaceuticals are essential components of viable nuclear medicine practice. C&RD manufactures a wide range of radiopharmaceuticals used in diagnostic medical imaging, as well as for radiotherapy. Products are manufactured according to the international and Saudi Food and Drug Authority (SFDA) standards of Good Manufacturing Practices (GMP), as well as in adherence to the ISO 9001 Quality Management System (QMS). The high quality products are supplied to some 50 nuclear medicine centers throughout the Kingdom.

Radiopharmaceuticals manufactured at the C&RD facility are characterized by the relatively short to ultra-short half-life of the radioisotope contained within. Therefore, the optimum utilization of these radiopharmaceuticals necessitates on-site availability of a particle accelerator (cyclotron) which is capable of transforming non-radioactive atoms into radioactive atoms. At the C&RD facility, three cyclotrons are currently dedicated to producing several essential radioisotopes, which are transformed into radiopharmaceuticals, and subsequently qualified as suitable for human use through rigorous testing and quality assurance.

Research activities of the C&RD are focused on developing new radioisotopes and radioactive molecular probes with potential usefulness in molecular imaging and therapy. The facility comprises of appropriate equipment, including a micro-PET/CT for in vivo studies of the new radiotracers for achieving translational research from bench to the bed-side.

C&RD's multi-disciplinary staff is a blend of engineers, chemists, radiochemists, radiopharmacists, and quality control chemists all working toward KFSH&RC's goal of providing the specialty services in patient care. The Department is committed to the policy of Quality in Performance and Pride in Achievement.

Mission

The mission of C&RD is to provide diagnostic and therapeutic radiopharmaceutical products that are manufactured by employing the highest quality standards, and to make the Kingdom of Saudi Arabia self-sufficient in all its radiopharmaceutical requirements.

Objectives

The multi-disciplinary composition of C&RD mandates all sections of the Department to have well defined goals and objectives that are collectively aimed at achieving the missions of not only the Department but also those of the Research Centre and the Hospital. These include:

  • Manufacturing diagnostic medical imaging products (radiopharmaceuticals) in compliance with the national and international standards of quality, purity, efficacy and safety.
  • Developing protocols and procedures for on time, every time supply of products to the customers.
  • Maintaining a comprehensive QMS (GMP and ISO 9001) for maximum quality and quality assurance in the radiopharmaceuticals.
  • Upgrading technologies and resources for achieving comprehensiveness in radiopharmaceuticals manufacturing.
  • Nurturing a stimulating work environment and providing opportunities to all staff for continued professional development, education, and training.
  • Developing staff with maximum number of Saudi national along with good mix of experience and expertise from abroad.
  • Engaging in collaborations with scientists within the Research Centre, KFSH&RC and external institutions in developing collaborative research projects, staff development and technology transfers.
  • Developing efficient and reliable methods for radioisotope production, and developing methods for radiolabelling biomolecules.

Achievements:

 

The unique program that produced the first radiopharmaceutical batch in 1983 has progressed steadily for over 30 years to the current capability of manufacturing several radioisotopes which are transformed into a wide range of radiopharmaceutical products. The high quality of products is substantiated from customer satisfaction and the record of diminutive untoward reaction to the patient.

Continued commitment of providing the specialty services to patients, KFSH&RC has completed the new expansion of C&RD facility to house three cyclotrons, a Tc-99m generators manufacturing facility and a “Cold Kits” manufacturing facility to provide over 95% of the all radiopharmaceutical needs in the Kingdom with surplus capacity for export to neighboring countries.

Today, the impressive product lineup of C&RD boasts of almost 20 different radiopharmaceuticals for diagnostic as well as therapeutic applications, which include:

Radiopharmaceutical

Application

Thallous (Tl-201) Chloride Injection

Myocardial Perfusion

Gallium (Ga-67) Citrate Injection

Tumors, Abscess

Rubidium/Krypton (Rb-81/Kr-81m) Generator

Lung Perfusion

Sodium Iodide (I-123) Capsules

Thyroid Function

Sodium Iodide (I-123) Oral Solution

Thyroid Function

Iodohippuran (I-123 OIH) Injection

Renal Function

m-Iodobenzylguanidine (I-123 mIBG) Injection

Adrenal Tumors

2-Fluorodeoxyglucose (F-18 2FDG) Injection

Oncology PET Scans

Sodium Fluoride (F-18 NaF) Injection

Bone PET Scans

Fluorocholine (F-18 FCH)

Neoplasm, Prostate and Brain Tumors

Fluorothymidine (F-18 FLT)

Proliferating tissue (primarily cancers)

Fluorodopamine (F-18 DOPA)

Dopamine receptors; AA transporters

Ammonia (N-13 NH3) Injection

Cardiac PET Scans

Sodium Iodide (I-131) Capsules

Thyroid Tumor Therapy

Sodium Iodide (I-131) Oral Solution

Thyroid Tumor Therapy

m-Iodobenzylguanidine (I-131 mIBG) Injection (Diagnostic)

Adrenal Tumors

m-Iodobenzylguanidine (I-131 mIBG) Injection (Therapeutic)

Adrenal Tumor Therapy

Urea (C-14) Capsules

Detection of H. Pylori Infection

Technetium (Mo-99/Tc-99m) Generator

Diverse applications

 

As of 2015, C&RD has manufactured over 32,000 batches of products with distribution of over 350,000 unit doses to various hospitals throughout the Kingdom of Saudi Arabia and beyond. The demand, and consequently the supply of our products have increased dramatically over the last few years, as depicted in the graph below:

 

 

Certificates:

  • ISO 9001:2000 Quality Management System Certification: 2001-2008
  • ISO 9001:2008 Quality Management System Certification: 2009-2015

 Awards:

  • Performance Award 2002, to the Cyclotron Section, for “Extra long hours and keeping the old horse running”.
  • Performance Award 2002, to the Radiopharmaceutical Production Section, for “Quality products and production”.
  • Performance Award 2002, to the Quality Control/Quality Assurance Section, for “Their meticulous attention to detail, ensuring the best quality products are produced”.

 

Publications:

     1.AlJammaz, I., Al-Otaibi, B., Amer, S., Al-Hokbany, N., Okarvi, S., Novel synthesis and preclinical     evaluation of folic acid derivatives labeled with (18)F-[FDG] for PET imaging of folate receptor-positive tumors, Nucl Med Biol 39 (2012) 864-870.

  1. S. Okarvi and I. AlJammaz, Preparation and evaluation of bombesin peptide derivatives as potential tumor imaging agents: effects of structure and composition of amino acid sequence on in vitro and in vivo characteristics, J. Nucl. Med. Biol, 2012;39(6):795-804.
  1. AlJammaz, I., Al-Otaibi, F. Al-Rumayan, S. Al-Yanbawi, S. Amer and S. B., Amer, S., N., Okarvi, S., Development and preclinical evaluation of new 124I-folate conjugates for PET imaging of folate receptor-positive tumors, J. of Nuclear Medicine and Biology, 41:457-463, 2014.
  1. AlJammaz, I., Al-Otaibi, B., Amer, S., Al-Hokbany, N., Okarvi, S., Development and preclinical evaluation of new 68Ga-NOTA-folate conjugates for PET imaging of folate receptor-positive tumors, Anticancer Research, 34, 6745-56, 2014.
  1. AlJammaz I., Al-Otaibi B. and Okarvi S., Novel Synthesis and Initial Preclinical Evaluation of 18F-[FDG] Labeled Rhodamine: A Potential PET Myocardial Perfusion Imaging Agent, J. of Nuclear Medicine and Biology, 42, 804-08, 2015.

In press

1-S. M. Okarvi, I. AlJammaz, Preparation and evaluation of the tumor-specific antigen-derived synthetic mucin 1 peptide: A potential candidate for the targeting of breast carcinoma, J. of Nuclear Medicine and Biology, In Press.

2-F. Al-Rumayan, S. Al-Yanbawi, AlJammaz, I., Development of a nickel-based electroplated krypton-81m target system, Applied Radiation and Isotopes, In Press.

C&RD Contact Details:
Tel.:       +966-11- 4427856; +966-11-464-7272 Ext.: 31751; 31769; 77645; 77646
Fax:       +966-11- 442-4743
Email:   radiopharma@kfshrc.edu.sa

 

CYCLOTRON Section - Riyadh
RADIOPHARMACEUTICALS PRODUCTION Section - Riyadh
RESEARCH & DEVELOPMENT Section - Riyadh

Gallery

Accreditations & Awards